Validation of Candidates

Li J, Orlandi R, White CN, Rosenzweig J, Zhao J, Seregni E, et al. Independent validation of candidate breast cancer serum biomarkers identified by mass spectrometry. Clin Chem 2005 51(12) 2229-2235. 

Thienpont LM, Van Nuwenboeg JE, Reinauee H and Stockl D (1996) Validation of candidate reference methods based on ion chromatography for determination of total sodium, potassium, calcium and magnesium in serum through comparison with flame atomic emission and absorption spectrometry. Clin Biochem 29 501-508. 

Preliminary consideration of candidate materials, processes and tooling factors, configuration, thicknesses in section, ribs, bosses, holes, surface characteristics, color, graphics, decoration, and assembly methods will begin to impose some discipline on the product design as it evolves. In the middle and latter phases of the design cycle, two or three concepts should make their validity apparent to all involved. With luck (logic), one will... 

Shen M, Xiao Y, Golbraikh A, Gombar VK, Tropsha A. Development and validation of k-nearest-neighbor QSPR models of metabolic stability of drug candidates. J Med Chem 2003 46 3013-20. 

Two problems were identified with the GCR production, compared to me-teoritic composition the 7Li/6Li ratio ( 2 in GCR but 12 in meteorites) and the nB/10B ratio ( 2.5 in GCR but 4 in meteorites). Modern solutions to those problems involve stellar production of 70% of 7Li (in the hot envelopes of AGB stars and/or novae) and of 40% of nB (through //-induced spallation of 12C in SNII). In both cases, however, uncertainties in the yields are such that observations are used to constrain the yields of the candidate sources rather than to confirm the validity of the scenario. 

Following validation, the candidate method is referred to as a level 1, 2, or 3 method depending on the level of pharmaceutical development that the method is intended to support (see Table 1). 

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